BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM PUMP

    MDR report key: 10792032 · Received November 4, 2020

    Report

    Report Number
    MW5097658
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    October 27, 2020
    Report Date
    November 2, 2020
    Manufacturer
    REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS RECEIVING VANCOMYCIN 2 GRAM IV EVERY 24 HOURS. LABS WERE OBTAINED ON (B)(6) 2020 WITH A VANCOMYCIN TROUGH OF 8.2 AND A CREATININE OF 0.8 (CRCL OF 129 ML/MIN). ON (B)(6) 2020 LABS WERE OBTAINED AGAIN WITH A VANCOMYCIN 83 AND AN ELEVATED CREATININE OF 7.4 (CRCL OF 14 ML/MIN). THE PATIENT WAS SWITCHED FROM A FREEDOM PUMP TO AN EASY PUMP ON 10/21. THE EASY PUMP WAS ONE BULB WITH VANCOMYCIN 2 GRAM IN IT TO RECEIVE EVERY 24 HOURS. IT WAS CONFIRMED THAT THE SYRINGES FOR THE FREEDOM PUMP DO NOT FIT ON THE EASY PUMP. THE PATIENT WAS ADMITTED ON (B)(6) 2020 AFTER A CALL FROM HIS PCP. VANCOMYCIN WAS DISCONTINUED AND WAS INITIATED ONTO DAPTOMYCIN TO ALLOW HIS KIDNEY FUNCTION TO RECOVER. THE PATIENT HAS ALLERGIES TO PENICILLIN'S, BACTRIM, AND TETRACYCLINES WITH THE REACTION BEING ANAPHYLAXIS, SHORTNESS OF BREATH, AND SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247843 FREEDOM PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS 76054430
    1247844 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization